EPIQ Series Diagnostic Ultrasound System
K240980Philips Ultrasound LLC · cleared 2024-10-07 · product code IYN · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“The purpose of this Traditional 510(k) Pre-Market Notification is to introduce the 3D Auto TV (Tricuspid Valve) software application onto the EPIQ Series Diagnostic Ultrasound Systems.”
source quote (p.11)
“The 3D Auto CFQ algorithm quantifies mitral regurgitation volume and flow rate from acquired 3D color flow images. The greyscale information from these images is used to generate a 3D model of the mitral valve, which is used as an input along with the 3D color data into the 3D Auto CFQ flow algorithm. The 3D Auto CFQ algorithm uses a fluid dynamic model of an incompressible fluid (blood) traveling through an irregular-shaped (i.e., nonround) orifice.”
Validation studies (3)
Retrospective clinical
sample size not stated
endpoints: agreement of automated performance with 4D Cardio-View software; annulus size; annulus shape; bias for automation performance; distance (size); circumference (shape)
standards: IEC 62304 Medical device software - Software life cycle processes, 2006 + A 2015, ISO 14971 Medical devices- Application of risk management to medical devices, 2019
Bench
sample size not stated
endpoints: mean relative error; limits of agreement
Retrospective clinical
sample size not stated
endpoints: limits of agreement for regurgitant volume; bias for mean difference; peak regurgitant flow output correlation with 2D PISA methodology
standards: IEC 62304 Medical device software - Software life cycle processes, 2006 + A 2015, ISO 14971 Medical devices- Application of risk management to medical devices, 2019
Reported performance (0 observations)
FDA source did not state a quantitative performance metric — non-reporting is itself the signal.
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
- recall_reason_pattern
Software/algorithm-related recall in product code IYN (Philips Ultrasound, LLC, initiated 2025-10-31): "Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining." Recalling firm matches this device's applicant.
first seen 2026-07-08 · recall res_event_number:97843
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K253595 (decision 2026-03-27) from Philips Ultrasound, LLC for a matching device line ("EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K253595
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K251651 (decision 2025-10-09) from Philips Ultrasound, LLC for a matching device line ("EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K251651
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K251455 (decision 2025-07-24) from Philips Ultrasound LLC for a matching device line ("EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K251455
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K250886 (decision 2025-06-18) from Philips Ultrasound LLC for a matching device line ("EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K250886
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K243793 (decision 2025-05-21) from Philips Ultrasound LLC for a matching device line ("EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K243793
- …and 7 more.
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).